A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
NCT ID: NCT04611724
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2020-12-01
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study.
Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication.
Response evaluation will be done every 6 weeks.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FOLFIRINOX
oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours
FOLFIRINOX
oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FOLFIRINOX
oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Origin in the anterior wall or dome of the bladder Predominant invasion of muscularis or deeper tissues No obvious origin from the overlying urothelium (relative normal-looking urothelial mucosa) No primary adenocarcinoma elsewhere
* Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
* No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous 5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim is allowed if it ended more than 6 months before enrollment.
* Measurable disease according to RECIST v1.1 criteria
* ECOG performance status 0 or 1
* Age 19 years or older
* Adequate cardiac function
* Adequate bone marrow, hepatic, and renal function Hematology
* Life expectancy more than 3 months
* Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted unless the lesion is the only measurable lesion
* Uncontrolled CNS metastasis (brain and/or leptomeningeal metastasis)
* Grade 2 or more peripheral neuropathy
* Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
* Pregnancy or breast feeding, or intention of becoming pregnant during study treatment or within 6 months after final dose
* Other severe acute or chronic medical or psychiatric condition
* Chronic diarrhea
* Clinically significant cardiac disease (heart failure, coronary artery disease, and/or arrhythmia)
* Hypersensitivity to study medication
* treatment with a prohibited medication or anticipation of need for prohibited medication ( section 5.5 )
19 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Green Cross Corporation
INDUSTRY
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jae-Lyun Lee
professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jae -Lyun Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jae-Lyun Lee, Professor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N, Miyashita K, Mizuno N, Tsuji K, Okusaka T, Furuse J. A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2018 Jun;81(6):1017-1023. doi: 10.1007/s00280-018-3577-9. Epub 2018 Apr 9.
Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. doi: 10.1159/000091635.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ULTIMA
Identifier Type: -
Identifier Source: org_study_id